Aromalief Cozy Vanilla Pain Relief Cream

Description

Aromalief Cozy Vanilla Pain Relief Cream is a topical formulation designed for pain management. The cream incorporates a blend of active ingredients aimed at providing localized relief. It is presented in a cream dosage form, characterized by its smooth texture and pleasant vanilla aroma. The product is intended for application to the skin, targeting areas of discomfort.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

• Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

• Discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop.

Warnings and Precautions

For external use only; contact with eyes should be avoided to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop. These actions are crucial to ensure patient safety and appropriate management of their condition.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additionally, pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to use to assess any potential risks associated with the product.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that the condition worsens, symptoms persist for more than 7 days, or new symptoms occur, patients are advised to stop use and consult a doctor.

It is crucial to keep the product out of reach of children. If the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For patients who are pregnant or breastfeeding, it is important to consult a health professional before use to ensure safety.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Aromalief Cozy Vanilla Pain Relief Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is important for healthcare providers to assess the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and potential fetal impacts are not well characterized. Therefore, careful consideration and professional guidance are essential for women of childbearing potential who are considering the use of this medication.

Lactation

Lactating mothers are advised to consult a health professional if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should evaluate the potential risks and benefits before prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize complications.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional before using the medication to ensure safety for themselves and their child.

Additionally, healthcare providers should instruct patients to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop. This guidance is essential for ensuring patient safety and effective management of their health condition.

Storage and Handling

The product is supplied in packaging that ensures its integrity and quality. It is essential to store the product in a cool, dry place, maintaining a temperature range between 68ºF and 77ºF (20ºC to 25ºC) with a relative humidity not exceeding 65%.

Healthcare professionals should ensure that the product is not used if the seal is broken, torn, or missing, as this may compromise the safety and efficacy of the product. Proper handling and storage conditions are crucial to maintain the product's stability and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aromalief Cozy Vanilla Pain Relief Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)